Acupuncture for Residual Insomnia Associated With Major Depressive Disorder: A Placebo- and Sham-Controlled, Subject- and Assessor-Blind, Randomized Trial

Objective: To evaluate the efficacy and safety of acupuncture for residual insomnia and other residual symptoms associated with major depressive disorder (MDD).

Method: 150 participants having significant insomnia for more than 3 months and a history of MDD (both based on DSM-IV-TR criteria) were recruited from 4 psychiatric outpatient clinics in Hong Kong from May 2011 to August 2013 to receive 9 sessions of treatment over 3 weeks. They were randomized to receive acupuncture, minimal acupuncture, or placebo acupuncture. Primary outcome was sleep diary-derived sleep efficiency. Secondary outcomes included other sleep diary parameters, actigraphy, anxiety and depressive symptoms, daytime functioning, and adverse events.

Results: The mean difference in sleep diary-derived sleep efficiency at 1-week posttreatment was −1.40 (95% CI, −7.08 to 4.28) between the acupuncture and minimal acupuncture groups and was 3.10 (95% CI, −3.64 to 9.84) between the acupuncture and placebo acupuncture groups. A χ2 test showed that acupuncture produced a significantly higher proportion of participants achieving sleep-onset latency ≤ 30 minutes than did minimal acupuncture at 1-week posttreatment (P = .04). However, there was no significant between-group difference in most of the other outcomes. Treatment blinding was successful, as a majority of participants did not know which treatment they had received.

Conclusions: Acupuncture was well tolerated, but the efficacy was only mild and similar to that of minimal acupuncture and placebo acupuncture. A high proportion of patients remained clinically significantly affected by insomnia after treatment. The finding raises certain doubts about the value of acupuncture and underscores the difficulties in the treatment of residual insomnia in MDD.

Trial Registration: ClinicalTrials.gov identifier: NCT01707706